Mylan and Fujifilm Kyowa Kirin Biologics Receive European Marketing Authorization for Hulio®, Biosimilar Adalimumab
(WorldNews Netherlands)

HERTFORDSHIRE, England and PITTSBURGH and TOKYO, Sept. 20, 2018/PRNewswire / -- Mylan N.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for Hulio® (Product Code: FKB327), a biosimilar to AbbVie`s Humira® (adalimumab), for all indications. The authorization follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), which concluded that the development program including analytical, functional, clinical and immunogenicity data demonstrated biosimilarity with the reference product, Humira. The EC approval of Hulio applies to all 28 European Union (EU)...